JP4700658B2 - Test tape unit for blood glucose test - Google Patents

Description

The present invention relates to a test tape for analysis, a storage coil for supplying an unused test tape, a winding coil for winding the used test tape, and a test tape portion at a measurement site for applying body fluid. In particular, the present invention relates to a test tape unit for blood glucose testing. The present invention also relates to a test system for using such a test tape unit.

  For the self-diagnosis of diabetics, individual tests that are conventionally examined photometrically after the application of a small amount of sample to identify as accurately and reliably as possible the glucose concentration in the sample (blood or tissue fluid). A test strip is used. To improve user convenience, it has already been proposed to provide a number of tests on a test tape in the form of a tape cassette. Such a tape cassette is inserted into a compact portable device as a disposable part so that all necessary inspection processes can be executed automatically and quickly. In doing so, it should be noted that these consumable parts are mass-produced products where high requirements are imposed for the required reliability.

  In the international application 2005/006985 pamphlet, in this connection, a test tape guide portion curved in an arc shape for exposing a test tape portion for liquid application on the front side, and a reflection photometry method focusing on this portion. A measurement unit has been proposed. However, in such an arrangement with parallel arched rails, in the case of thin flexible test tapes, the central tape area is bent under tension in the free space between the rails, thereby providing an accurate optical alignment. There is a risk that scorching will be difficult. Such tape deformation has already been found to be a problem for measuring optics with a small radius of curvature and particularly short focal lengths.

  In order to take the removal measures here, it has been proposed to use an optical element in the form of a cylindrical lens, in particular in the form of a cylindrical lens, for the application tip, which converges the measuring light in the optical path of the photometer. However, as in the case of simple optical windows, in particular, these are particularly important for the required measurement accuracy, especially in terms of permeability, scratch strength, temperature stability, expansion rate, optical quality or other material parameters or errors It should be noted that high quality requirements are imposed as described in the international standard ISO10110.

  From the above, the problem at the basis of the present invention is that the test tape system proposed in the prior art continues to be improved and has special application advantages due to its simple manufacturability, in particular high measurement accuracy with a small load of test tape. Is to achieve.

  In order to solve this problem, combinations of features displayed in claims 1 to 20 are proposed. Advantageous embodiments and further developments of the invention result from the dependent claims.

[The invention's effect]
The present invention is presumed from the idea that no optical element or substantial window is provided in the region of the tape guide portion. That is, an optical element that interacts with an optical material when light enters the optical element should be avoided. Correspondingly, according to the present invention, the tape guide portion stretches the test tape portion flat at the measurement site, and at that time, the frame leg portion is evacuated from the optical element, that is, air is measured against the optical measurement on the back surface of the tape. It is proposed to have a flat support frame that surrounds and restricts only the filled measurement opening. This ensures good target accuracy and sufficient support for liquid application on the front side, while the test tape is narrowly defined with no significant deflection for optical measurements on the back side. The inner measurement aperture allows light incident and reflected light to pass as a simple optical path under conditions that always remain the same. On the other hand, it is not necessary to manufacture special optical members such as lenses, filters or solid windows, and the addition of energy efficient and protective tape transport is possible by avoiding tape shrinkage.

  Preferably, the frame legs of the support frame limit the measurement opening to a rectangular shape, thereby providing sufficient space for the light flux directed to the plurality of test tapes.

  A preferred embodiment takes into account that the support frame has two frame legs that extend side by side in the longitudinal direction of the test tape and their outer edge spacing is smaller than the width of the test tape. In this way, shielding against device contamination by the test solution can be achieved by overlapping test tape edges.

  Another improvement is achieved by the support frame having two frame legs extending parallel to the transverse direction of the test tape, the length of which corresponds at least to the width of the test tape.

  In this way, tape contraction in the deflection area can be avoided, so that a flat frame over-tension is supported.

  In order to further improve the tape guide, it is an advantage if the frame legs of the support frame that supports the test tape in its longitudinal direction are flattened into a strip. It is also preferable that the frame leg portion extending in the lateral direction of the tape is chamfered by the deflection angle portion for the test tape.

  In another advantageous embodiment, the support frame is formed by a flat upper surface of the protrusion of the tape guide, preferably tapered in the shape of a pyramid. This additionally improves the handling and hygiene conditions during liquid application.

  For application, it is also advantageous if the tape guide has a deflection ramp connected to the support frame in the longitudinal direction of the tape, and this deflection ramp forms an acute angle with the plane of the support frame.

  In order to protect the test tape against lateral deflection, the tape guide part can preferably have a side limiting part arranged outside the area of the support frame, so that it is accurate on the support frame. Center alignment is possible.

Furthermore, it is advantageous if the test tape can be supplied by driving the winding coil of the storage coil, and for flat holding, the test tape should be held under tension, preferably with a support force of 1 N or more.

  For mass production, an advantage arises when the support frame is molded in one piece. Such a molded article can preferably consist of polypropylene as an injection-molded article and is well shielded against scattering of external light by the black coloring of the optical region.

  When sample application and measurement are performed at the same location, no additional intermediate transport to the spaced apart measurement sites of the test tape portion that biased the sample is required. In this connection, bodily fluid can be applied to the free tape front side of the test tape portion supported on the support frame, while reflection photometry under free illumination of the measurement opening at the test tape portion resting on the support frame. This is advantageous when the method is measured from the back side of the tape.

  In order to simplify the use of the device, a measuring chamber is formed which is limited by the tape guide for the use of the measuring unit, the light source and the receiver of the measuring unit being above it via the measuring opening It is suitable when focused on above.

  Preferably, the tape guide portion is covered outward by the covering portion, and the support frame protrudes from the perforated portion of the covering portion.

  The test tape unit according to the invention is preferably formed as a tape cassette which is inserted into the test unit.

  The object of the invention is also a test system comprising a measuring unit, preferably operated by reflection photometry, a tape drive and a test tape unit according to the invention which can be used as a consumer.

  Hereinafter, the present invention will be described in more detail with reference to the embodiments schematically shown in the drawings.

  The tape cassette 10 shown in FIG. 1 allows a number of glucose tests to be performed on a blood sample collected by the patient himself at the site. For this purpose, the tape cassette 10 includes an analytical test tape 12 that can be pulled out of the storage coil 14 and can be wound around the winding coil 18 via the tape guide portion 16. In order to enable the application of body fluid (blood or tissue fluid) on the front side and the accurate measurement by reflection photometry on the back side, the body is clamped flat via a flat support frame 24.

  The test tape 12 is composed of a translucent carrier tape 26, and a test field 28 is attached to each front surface of the test tape 28 in a label shape. This includes dry chemicals that react to the analyte in the applied blood (glucose) and cause a measurable change in light back illumination when illuminated on the back side. For example, the carrier tape 26 is made of a film having a width of 5 mm and a thickness of about 10 μm, and a detection film having a thickness of 50 μm is attached to the front side of each part.

  Photometry is incident and reflected through a measurement aperture 32, framed by the support frame 24 during measurement, and an optical element such as a window filled with a lens, filter or object must be provided inside the aperture area. (However, if necessary, the measurement opening may be framed by a shading device). This allows a constant back-side focus or orientation of the optical measurement unit on the test tape portion 20 exposed flat through the measurement opening 32.

A tape drive that engages the boss 34 of the winding coil 18 allows the test tape 12 to be wound in order to continuously transport the test field 28 to the measurement location 22. At that time, a bearing force of about 2N is generated by friction in the region of the storage coil 14 and the tape guide 16 (here in particular the retracting seal 36), so that a flat placement on the support frame 24 is ensured. Therefore, the test tape 12 is set sufficiently under tension.

  The tape guide portion 16 is formed of an injection molded product made of polypropylene that simultaneously forms a carrier for the coils 14 and 18. In order to cover the tape guide part 16 outward, a cover part 38 having a passing part for exposing the support frame 24 which is easily obtained with a narrowed narrow side wall is provided.

  As best seen in FIG. 2, the support frame 24 is formed on the head portion 40 of the tape guide portion 16. The support frame is here formed by the flat upper surface of the projection 42 which tapers in a pyramid shape, so that a hygienic application of a small amount of blood is also facilitated. Deflection ramps 44, 46 are thereby connected to the support frame 24 so that the test tape 12 can be led out and introduced in the longitudinal walls facing each other in the cassette 10 when viewed in the longitudinal direction of the tape. Side limiters 48, 50 are also provided in this region, which protect the test tape 12 against lateral deflection, so that side slipping on the support frame 24 is avoided.

  As is apparent from FIG. 3, the support frame 24 has two frame legs 52, 54 extending along the test tape 16 guided thereon, and two frame legs 56 extending perpendicular thereto. , 58. The longitudinally extending frame legs 52, 54 are flattened in strips and have a mutual outer edge spacing less than the width of the test tape 16. By this method, the test tape 16 protruding to the side prevents blood from reaching the protrusion 42 during application. The laterally extending frame legs 56, 58 are chamfered to a radius of about 0.3 mm depending on the purpose at the deflection angle 43 with respect to the test tape 16 so that the test tape 16 is supported over its entire width. A length is specified. Thus, if the tape width is 5 mm, the frame legs 56, 58 have a length of 5 mm as well, while the measurement opening 32 has a length of 3 mm and a width of 2 mm. In addition to hygienic handling, the formation of the support frame 24 also achieves that the tightened test tape portion 20 is not bent at the measurement site.

  For ease of handling, the cassette 10 is inserted into the portable device 60 as a consumable material, which is shown as a block diagram in FIG. The apparatus 60 has a control and evaluation unit 62, a tape drive 64 acting on the boss 34 of the winding coil 18, and an optical measurement head 66 that engages the measurement chamber 30 on the cassette side.

  The measuring head 66 and the head portion 40 of the cassette 10 are shown in FIG. 4 in a cross-sectional view in the lateral direction of the test tape. The measurement head 66 includes a light source 68 and a light receiver 70 on a substrate 72. The light source 68 and the light receiver 70 are focused on the test field 28 through the transparent carrier tape 26 through the lenses 74 and 76 on the measurement head side. At that time, the light beams 78 and 80 on the transmission side and the reception side pass through the measurement chamber 30 and in particular the measurement aperture 32, and no other interaction with the optical element occurs. This method makes it possible to detect the test tape on a certain measuring surface by reflection photometry, and the optical path is not negatively influenced by the elements of the cassette 10.

It is the see-through | perspective view which cut | disconnected the tape cassette for blood glucose tests. It is an expansion perspective view of the head part of the tape guide part in the tape cassette of FIG. It is a top view of the head part of the tape guide part of FIG. Fig. 2 is a partially schematic illustration, partly cut away, of a test system with a used tape cassette.

Claims (14)

Analytical test tape (12), storage coil (14) for supplying unused test tape (12), wound coil (18) for winding used test tape (12), and body fluid and a tape guide portion for exposure to the test tape portion at the measurement site for the coating (22) (20) (16), a test tape unit,
The tape guide part (16) stretches the test tape part (20) flat at the measurement site (22), and at that time, the frame leg part (52, 54, 56, 58) is used for optical measurement. A test tape unit, characterized in that it has a flat support frame (24) that surrounds and restricts the inner measurement opening (32). 2. The test tape unit according to claim 1, wherein the frame legs (52, 54, 56, 58) of the support frame (24) limit the measurement opening (32) to a rectangular shape. The support frame (24) has two frame legs (52, 54) extending side by side in the longitudinal direction of the test tape (12), and their outer edge spacing is smaller than the width of the test tape (12). The test tape unit according to any one of claims 1 and 2. The test tape according to any one of claims 1 to 3, wherein the width of the measurement opening is 0.3 to 0.6 times the width of the test tape (12) when viewed in the transverse direction of the tape. unit. The frame leg (52, 54) of the support frame (24) extending in the longitudinal direction of the test tape (12) is flattened into a strip shape. Test tape unit. Chamfering the test tape (12) to the frame legs of the support frame extending in the transverse direction (24) (56, 58) is the deflection angle of the test tape (12) over a radius 0.2~0.5mm The test tape unit according to any one of claims 1 to 5, wherein A support frame (24) according to claim 1, characterized in that it is formed by the upper surface of the projection (42) of the tape guide portion tapering the corners pyramidal (16) Test tape unit. Tape guide portion (16) has a deflection slope (44, 46) connected to the tape longitudinal direction on the support frame (24), an acute angle in the range of the deflection slope (44, 46) is 7 0 ° to 85 ° The test tape unit according to any one of claims 1 to 7, wherein: 9. The test tape unit according to claim 1, wherein the body fluid can be applied to the free tape front surface of the test tape portion (20) supported on the support frame (24). 10. The reflection photometry measurement is performed from the back side of the tape under free irradiation of the measurement opening (32) at the test tape portion (20) mounted on the support frame (24). The test tape unit according to item 1. 11. The tape guide portion (16) is covered outward by a covering portion (38), and the support frame (24) protrudes from a perforated portion of the covering portion (38). A test tape unit given in any 1 paragraph. The test tape unit according to any one of claims 1 to 11, characterized in that the test tape unit is formed as a tape cassette (10) to be inserted into the test apparatus. Test system comprising a measuring unit for operation, a tape drive, a test tape unit (10) according to any one of claims 1 to 12 can be used as consumables in reflection photometrically. Test tape part measuring unit is exposed to (20) optically scanned via at least one light beam, characterized by transmission without interaction of light chemical elements light flux in the region of the measuring opening The test system according to claim 13.

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